Knee OsteoarthritisNCT00991445
Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty
A study testing Minimal Invasive Surgery and Conventional exposure in people with Knee Osteoarthritis, run by Region Örebro County at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Minimal Invasive Surgery and Conventional exposure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- May 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for unicompartmental knee arthroplasty
- Aged 20-80 yrs
- ASA physical status I-III and mobility indicating normal postoperative mobilization
Who cannot join
- Known allergy or intolerance to local anesthetics, ASA or NSAID
- Serious liver-, heart- or renal decease
- Rheumatoid arthritis
- Chronic pain or bleeding disorder
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Dept. of Orthopedic Surgery
Örebro, Örebro County, SE-70185
Per Essving, MD, +46196021000, per.essving@orebroll.se
Kjell Axelsson, Professor, +46196021000, kjell.axelsson@orebroll.se
About this study
Official title: Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty
The purpose of this study is to determine whether Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.
Read the detailed description
Postoperative pain is often moderate to severe following unicompartmental knee arthroplasty. In order to reduce postoperative pain and improve mobilization the minimal invasive technique was developed. After a 8-10 cm skin incision, a medial parapatellar capsule incision in made. The rectus tendon or the vastus medialis are not incised and the patella is not everted.
In recent years The Local Infiltration Analgesia (LIA) technique has been developed to reduce postoperative pain. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.
The aim of this study is to investigate if Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.
- Conditions
- Knee Osteoarthritis
- Being tested
- Minimal Invasive Surgery, Conventional exposure
- Keywords
- Unicompartmental knee arthroplasty, Surgical exposure, Minimal invasive surgery, Local Infiltration Analgesia, Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal Invasive SurgeryProcedure or surgery
After a 8-10 cm skin incision, a medial parapatellar capsule incision is made. The vastus medialis muscle or the rectus tendon are not incised, nor is the patella everted. The patella is merely pushed slightly aside when the bone cuts are made and the prostheses are cemented in place. Local Infiltration Analgesia is used.
Conventional exposureProcedure or surgery
After a 15-20 cm midline skin incision is made, a medial parapatellar capsule incision is made. The incision is carried up through the insertion of the vastus medialis and into the rectus tendon. The patella is everted. The bone cuts are made and the prostheses are cemented in place. Local Infiltration Analgesia is used.
| Study group | Role | What they receive |
|---|---|---|
| Group MIS | Active comparator | Minimal Invasive Surgery Receives: Procedure: Minimal Invasive Surgery |
| Conventional Exposure | Active comparator | Not described Receives: Procedure: Conventional exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fulfilling discharge criteria
Measured: 0-2 weeks
Secondary outcomes (5)
Pain intensity
Measured: 0-3 months
Hospital stay
Measured: 0-2 weeks
Morphine consumption
Measured: 0-48 hours
Knee function
Measured: 0-3 months
Patient satisfaction
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Investigators
- Kjell Axelsson, Professor, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991445
- Sponsor's protocol ID
- RAK-Incision
- Status last verified
- Oct 2009
- First submitted
- 7 Oct 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Essving P, Axelsson K, Otterborg L, Spannar H, Gupta A, Magnuson A, Lundin A. Minimally invasive surgery did not improve outcome compared to conventional surgery following unicompartmental knee arthroplasty using local infiltration analgesia: a randomized controlled trial with 40 patients. Acta Orthop. 2012 Dec;83(6):634-41. doi: 10.3109/17453674.2012.736169. Epub 2012 Oct 8.
PubMed 23043272
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00991445
- Acronym / sponsor ID
- RAK-Incision
- Conditions
- Knee Osteoarthritis
- Keywords
- Unicompartmental knee arthroplasty, Surgical exposure, Minimal invasive surgery, Local Infiltration Analgesia, Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.
Detailed description
Postoperative pain is often moderate to severe following unicompartmental knee arthroplasty. In order to reduce postoperative pain and improve mobilization the minimal invasive technique was developed. After a 8-10 cm skin incision, a medial parapatellar capsule incision in made. The rectus tendon or the vastus medialis are not incised and the patella is not everted.
In recent years The Local Infiltration Analgesia (LIA) technique has been developed to reduce postoperative pain. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.
The aim of this study is to investigate if Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group MIS | Active comparator | Procedure: Minimal Invasive SurgeryMinimal Invasive Surgery |
| Conventional Exposure | Active comparator | Procedure: Conventional exposure |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for unicompartmental knee arthroplasty
- Aged 20-80 yrs
- ASA physical status I-III and mobility indicating normal postoperative mobilization
Key exclusion criteria (4 listed)
- Known allergy or intolerance to local anesthetics, ASA or NSAID
- Serious liver-, heart- or renal decease
- Rheumatoid arthritis
- Chronic pain or bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal Invasive SurgeryAfter a 8-10 cm skin incision, a medial parapatellar capsule incision is made. The vastus medialis muscle or the rectus tendon are not incised, nor is the patella everted. The patella is merely pushed slightly aside when the bone cuts are made and the prostheses are cemented in place. Local Infiltration Analgesia is used. | Procedure or surgery | Group MIS |
| Conventional exposureAfter a 15-20 cm midline skin incision is made, a medial parapatellar capsule incision is made. The incision is carried up through the insertion of the vastus medialis and into the rectus tendon. The patella is everted. The bone cuts are made and the prostheses are cemented in place. Local Infiltration Analgesia is used. | Procedure or surgery | Conventional Exposure |
Primary outcome
Time to fulfilling discharge criteria
Time frame: 0-2 weeks
5 secondary outcomes
Pain intensity
Time frame: 0-3 months
Hospital stay
Time frame: 0-2 weeks
Morphine consumption
Time frame: 0-48 hours
Knee function
Time frame: 0-3 months
Patient satisfaction
Time frame: 0-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2009.
- Derived from this study: PubMed 23043272Essving P, Axelsson K, Otterborg L, Spannar H, Gupta A, Magnuson A, Lundin A. Minimally invasive surgery did not improve outcome compared to conventional surgery following unicompartmental knee arthroplasty using local infiltration analgesia: a randomized controlled trial with 40 patients. Acta Orthop. 2012 Dec;83(6):634-41. doi: 10.3109/17453674.2012.736169. Epub 2012 Oct 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjell Axelsson, Professor principal investigator
Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal Invasive Surgery and Conventional exposure in people with Knee Osteoarthritis, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to fulfilling discharge criteria (time frame: 0-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2009.